Thursday, July 13, 2006

'Noninferiority' trials review; sham acupuncture

Yes we just received a large bolus of comment-spam--too much for me to tidy up at once so sorry about that.

2) Annals of Internal Medicine has recently published two articles of note.
First is an analysis and discussion of 'noninferiority' trials. These tend to be randomized, controlled trials which instead of a placebo control use an active, 'standard-of-care' control in situations where it is considered unethical to offer placebo and not an active treatment. A trial comparing a novel chemotherapy to an established regimen would be one example; a trial comparing a novel analgesic compound, formulation, or route to, say, oral morphine would be another example pertinent to palliative care. The outcome in these trials then is to show that the novel therapy is as good as, noninferior to, some standard treatment. These trials are relatively common in palliative care, particularly pain trials, and are fraught with methodologic problems which are what this review discusses. It discusses these in a detailed, statistical manner; but for those of us who are interested in these things this is a paper worth reading.

Next is a randomized controlled trial of acupuncture vs. sham acupuncture vs. 'standard care' for knee osteoarthritis pain. Sham acupuncture here was using needling at defined distances away from standard acupunture points; both acupuncture groups received 10 visits total over 6 weeks. The standard care group received 10 clinic visits and diclofenac or rofecoxib (our old friend Vioxx). The acupuncture groups were blinded as to whether they received sham or 'therapeutic' acupuncture; the standard group of course was not blinded. ~1000 subjects were studied. Pain and function improved in all groups (this is not surprising); it improved more in the acupuncture groups vs. the so-called standard care group (this is also not surprising). What is of note is that the sham acupuncture group did just as well as the 'therapeutic' acupuncture group suggesting acupuncture's effect is from placebo or from needling itself (irrespective of where the needles are placed). This is contrary to two other studies which found therapeutic acupuncture superior over sham in the treatment of knee OA pain and disability. This study was larger than these, but there are significant methodologic differences between them all to really make any sense of this. To me, acupuncture is very much still a therapy in search of a (medical) indication.

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